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QuantiFERON-TB Gold

eD-H Order Code

LAB3382

Specimen Collection Information

QuantiFERON®-TB Gold Plus — blood collection

Samples collected for QuantiFERON testing must be collected into specially designed tubes.•    QuantiFERON Nil tubes (gray cap with white ring)•    QuantiFERON TB1 tubes (green cap with white ring)•    QuantiFERON TB2 tubes (yellow cap with white ring)•    QuantiFERON Mitogen tubes (purple cap with white ring)

These tubes must be used, no substitutions with other sample tubes are permitted.


1.    Blood Collection

Collect 1 mL blood by venipuncture into each QFT®-Plus Blood Collection Tube beginning with the GRAY topped tube first. To prevent invalid or false positive results the tubes must be filled in the following order: Gray, Green, Yellow, Purple
QuantiFERON Tubes are calibrated to collect 1 mL of blood, if the level of blood in the QuantiFERON tube is outside the range of the black mark on the side of the tube label, obtain another sample.

NOTES:
QuantiFERON tubes fill slowly — hold the tube on the needle for 2–3 seconds after flow ceases.

If a “butterfly needle” is used, the attached tubing must be filled with blood before drawing into the QuantiFERON tubes. This is done by first drawing 1 - 2 mL of blood into a plain discard tube (not supplied) before filling the QuantiFERON tubes. Failure to complete this step may result in invalid test results.

2.    Tube shaking.

Immediately after filling, shake tubes 10 times just firmly enough to ensure that the inner surface of the tube is coated with blood (to dissolve antigens on tube walls).

Important: Overly vigorous shaking may   cause   gel   disruption   and   could   lead   to aberrant results.

Label tubes appropriately according to hospital procedure and send to laboratory for incubation and testing.

Specimen Transport Temperature

Ambient

Reference Ranges / Critical Values

Assay Gender Age Range Normal Range Critical Values Units
Quantiferon TB All 0 Minutes – 150 Years Negative    

Specimen Stability

Samples must arrive within 16 hours of collection.

Chemistry Blood and Urine Analyte Stability Chart

Additional Specimen Instructions

Standard phlebotomy tubes are not acceptable.

QuantiFERON-specific tubes are stored at DHMC Level 3 Blood Draw area, Southern NH labs and draw stations.

This test requires that the collection tubes be incubated at 37° C as soon as they reach the DHMC Pathology lab and within 16 hours of being drawn.
Before incubation, the tubes must be maintained at Ambient. Samples must be incubated at 37° C for 16-24 hours before submission to Special Chemistry. Only specimens incubated 16-24 hours are acceptable. Once incubated, the samples can be stored refrigerated for 72 hours prior to being spun.

Interpretive Data

Assay Display Interpretive Data
Quantiferon TB Reference range: Negative The performance of the Quantiferon-TB Gold IT test has not been extensively evaluated in children younger than 17 years of age. Therefore there is no published data to document the performance of QFT-G in this age group.
Quantiferon TB Interp The performance of the QFT-Plus assay has not been extensively evaluated with specimens from the following individuals: Individuals who have impaired or altered immune functions such as those who have HIV infection or AIDS those who have transplantation managed with immunosuppressive treatment or others who receive immunosuppressive drugs (e.g. corticosteroids methotrexate azathioprine cancer chemotherapy) those who have other clinical conditions such as diabetes silicosis chronic renal failure and hematological disorders (e.g. leukemia and lymphomas) or those with other specific malignancies (e.g. carcinoma of the head or neck and lung). Individuals younger than age 17 years Pregnant women. Diagnosis of or the exclusion of tuberculosis disease and assessment of Latent Tuberculosis Infection (LTBI) requires a combination of epidemiological historical Medical and diagnostic findings that should be taken into account when interpreting QFT-Plus results.

Day(s) Performed

Monday through Friday

CPT(s)

86480

Performing Lab Section

Chemistry